Based on the book written by Edmond W. Israelski and William H. Muto: Risk Management: How to Assess and Control Risk Related to Human Error in Products and Systems
Risk management is one of the most critical steps of the Human Factors Engineering process. It is invaluable particularly in the healthcare and medical device industries. After all, if engineers can't identify and then mitigate the elements of a product or system that could lead to harm, serious negative consequences for users, patients, and the company can occur.
However, risk management can be challenging to understand! There are so many strategies, tools and Do Not’s, a beginner can feel overwhelmed.
Unlike other books on risk management, Israelski and Muto offer step by step instructions on how to apply popular tools such as FMEA (failure modes and effects analysis) and FTA (fault tree analysis) through a human centered perspective.
I highly recommend their book to anyone wishing to learn more about the topic as it relates to use error and human interactions with products and systems. With two detailed case studies - an AED defibrillator and a blood glucose meter - this book is an excellent introduction to an often complicated, but essential step of the human factors engineering process.
While I encourage you all to buy your own copy and derive your own insights, here is a summary of some chapters that resonated with the Loring Human Factors (LHF) Team.
To read, expand each section below:
Importance of Risk Management
Since people’s perception of risk is often incorrect (ex: people have a greater fear of airplane crashes than car crashes, even though airplane crashes occur less frequently), it is important to establish a robust and thorough risk management process to avoid biases and assumptions during device development. Israelski and Muto recommend gathering stakeholders from different functions (clinical, regulatory, quality, engineering, etc.) to form a diverse risk management team. Different perspectives will ensure the team is able to capture most foreseeable risks, assign appropriate severity ratings, and develop comprehensive mitigations. Although not specifically mentioned by the authors, bringing in external consultants with diverse industry experience can be helpful in drafting the risk documentation, since their expertise may bring in a fresh perspective on device usability. Our team has helped many of our clients draft the URRA according to FDA expectations and most importantly, conducted numerous studies that validate mitigations and identify unexpected risks. Of course, as the authors rightfully point out, risk management does not end after you have identified, prioritized, and mitigated risks through an HF validation study. After a product/system is released to the public, the risk management team must then conduct post-market surveillance in case a new risk is found. Just like many other deliverables involved in a product life cycle, risk assessment and management reports are “living documents.”
Risk Terminology and Tools
Failure Modes and Effects Analysis: FMEA
Fault Tree Analysis: FTA
Conclusion:
There are plenty more topics discussed in the book, so we’ll wrap up here to prevent additional spoilers. If you want to see a uFMEA and FTA conducted in their entirety, we (*once again*) encourage you to buy the book and take a look at Chapters 5 and 6, where Israelski and Muto apply these tools to an AED defibrillator and a blood glucose meter.
Once you do, we'd love to hear your thoughts. Do you agree or disagree with their stance about omitting likelihood in the FDA’s uFMEA format? Do you conduct a uFMEA or FTA differently that described? Comment below or reach out to Loring HF to start a conversation!
References:
Israelski, E.W., & Muto, W.H. (2022). Risk management: How to assess and control risk related to human error in products and systems. Human Factors and Ergonomics Society.